YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 228 drug applications between 9 March 2023 and 15 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 37 drug names.
2023/03/09 – 2023/03/15
- New acceptances this week
- 228
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 10
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
228filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 105 |
| Generic | 50 |
| New drug | 43 |
| Import | 19 |
| Import re-registration | 6 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 156 |
| Therapeutic biologic | 37 |
| TCM | 29 |
| Biologic | 5 |
| Prophylactic biologic | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 2 | 2 | 34 |
| 2 | 氧 · No verified English name | 2 | 2 | 15 |
| 3 | Famotidine Injection | 2 | 2 | 8 |
| 4 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 5 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 6 | Dimethyl Fumarate Delayed-release Capsules | 2 | 1 | 0 |
| 7 | Empagliflozin And Linagliptin Tablets | 2 | 1 | 0 |
| 8 | Amlodipine Besylate and Atorvastatin Calcium Tablets | 2 | 1 | 2 |
| 9 | 氯雷他定糖浆 · No verified English name | 2 | 1 | 7 |
| 10 | Caspofungin Acetate for Injection | 2 | 1 | 8 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
145 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Tianjin He Zhi Pharma Group Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | MSD Pharma (Singapore) Pte. Ltd | 4 | 2 | 0 |
| 5 | Qilu Pharmaceutical (Hainan) Co., Ltd | 4 | 2 | 4 |
| 6 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Guangxi Ji Min Tang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Guangxi Yu Yuan Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 3 | 2 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/15Import · Class 1 | Tarlatamab · No verified English nameJXSL2300054 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/03/15Import · Class 1 | Tarlatamab · No verified English nameJXSL2300053 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/03/15Import · Class 1 | Tarlatamab · No verified English nameJXSL2300052 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/03/15Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2300792 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/03/15Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2300791 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/03/15New drug · Class 1 | FP002注射液 · No verified English nameCXSL2300192 | Guangdong Fei Peng Pharmaceutical Co., Ltd. romanized |
| 2023/03/15New drug · Class 1 | MWN101注射液 · No verified English nameCXSL2300191 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2023/03/15New drug · Class 1 | MWN101注射液 · No verified English nameCXSL2300190 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2023/03/15New drug · Class 3.3 | BR201注射液 · No verified English nameCXSL2300189 | Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/03/15New drug · Class 2.2 | 赛帕利单抗注射液 · No verified English nameCXSL2300188 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/15New drug · Class 1 | Domvanalimab注射液 · No verified English nameCXSL2300187 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/15New drug · Class 1 | TNM006注射液 · No verified English nameCXSL2300186 | Shenzhen Shi Zhi Xin Bio Technology Co., Ltd. romanized |
| 2023/03/15New drug · Class 1 | PB-718注射液 · No verified English nameCXHL2300314 | Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/03/15New drug · Class 1 | HS336片 · No verified English nameCXHL2300313 | Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2023/03/15New drug · Class 1 | HS336片 · No verified English nameCXHL2300312 | Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2023/03/14Import · Class 3.1 | 美泊利珠单抗注射液 · No verified English nameJXSS2300027 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2023/03/14Import · Class 3.1 | 美泊利珠单抗注射液 · No verified English nameJXSS2300026 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2023/03/14Import · Class 1 | DS-1062a · No verified English nameJXSL2300051 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2023/03/14Import · Class 2.4 | Inclisiran注射液 · No verified English nameJXHL2300047 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2023/03/14Generic · Class 3 | Peramivir InjectionCYHS2300785 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized |
| 2023/03/14Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2300779 | Hunan Chun Jian Pharmaceuticals Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/03/14Generic · Class 3 | Cefazolin Sodium for InjectionCYHS2300778 | Sen Miao (Shandong) Pharma Co., Ltd. romanized; Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized |
| 2023/03/14Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2300777 | Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized |
| 2023/03/14Generic · Class 3 | Nicorandil for InjectionCYHS2300776 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2023/03/14New drug · Class 2.4 | CMAB009注射液 · No verified English nameCXSS2300012 | Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized |
| 2023/03/14New drug · Class 1 | TQC2731注射液 · No verified English nameCXSL2300185 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/03/14New drug · Class 1 | VUM02注射液 · No verified English nameCXSL2300184 | Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized |
| 2023/03/14New drug · Class 1 | VUM02注射液 · No verified English nameCXSL2300183 | Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized |
| 2023/03/14New drug · Class 2.1; 2.2; 2.4 | YMP透皮贴剂 · No verified English nameCXHL2300311 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2023/03/14New drug · Class 2.1; 2.2; 2.4 | YMP透皮贴剂 · No verified English nameCXHL2300310 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
50 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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